Sealing member for a catheter

ABSTRACT

A catheter includes a proximal end, a distal end, a tubular member, and an inner member extending through the tubular member. The inner member is movable axially relative to the tubular member. The catheter also includes a seal member including a first portion and a second portion. The seal member extends between the tubular member and the inner member. The first portion of the seal member remains stationary relative to the tubular member, and the second portion of the seal member remains stationary relative to the inner member during relative axial movement between the tubular member and the inner member.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a division of U.S. application Ser. No. 12/476,539,filed Jun. 2, 2009, now U.S. Pat. No. 8,167,845, which is herebyincorporated by reference in its entirety as though fully set forthherein.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The field of the invention relates generally to catheters and, morespecifically, to catheters having seals located in a distal portionthereof that prevent fluid passage during a surgical procedure.

2. Background Art

During surgical procedures that utilize a catheter, controlling fluidpassage through the catheter is important. It is particularly importantwhen the catheter includes inner channels that extend the length of thecatheter and have physical elements passing therethrough. For example,as illustrated in FIG. 1, a known basket electrode mapping catheter 100includes a first inner tube or rod member 102 that passes through asecond outer tubular member 104. As basket electrode 106 is extended andretracted, relative movement occurs between members 102 and 104. Toallow such relative movement, a space or gap 108 exists between members102 and member 104. It is through spaces, such as gap 108, that bloodand other bodily fluids can flow 110 unless they are impeded.

BRIEF DESCRIPTION OF THE INVENTION

In one aspect, a catheter is provided that includes a proximal end, adistal end, a tubular member, and an inner member extending through thetubular member. The inner member is movable axially relative to thetubular member. The catheter also includes a seal member including afirst portion and a second portion. The seal member extends between thetubular member and the inner member. The first portion of the sealmember remains stationary relative to the tubular member, and the secondportion of the seal member remains stationary relative to the innermember during relative axial movement between the tubular member and theinner member.

In another aspect, a basket electrode mapping catheter is provided thatincludes a proximal end, a distal end, a tubular member, an inner memberextending through the tubular member, and a basket electrode connectedto a distal end of the inner member. The catheter also includes a sealmember having a first portion and a second portion. The seal memberfirst portion contacts the tubular member. The seal member secondportion contacts the inner member. The seal member is configured toprevent fluid flow between the tubular member and the inner member.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic view of a prior art basket electrode mappingcatheter showing potential fluid ingress into the catheter.

FIG. 2 is a schematic view of a basket electrode mapping catheter inaccordance with one embodiment of the invention.

FIG. 3 is a schematic view of the basket electrode shown in FIG. 2including a collar.

FIG. 3A is an enlarged view of the collar shown in FIG. 3.

FIG. 4 is a cut-away view of a seal used in the catheter shown in FIG. 2with the inner member in an extended position.

FIG. 5 is a cut-away view of the seal shown in FIG. 4 with the innermember in a retracted position.

FIG. 6 is a cut-away view of an alternative seal used in the cathetershown in FIG. 2.

FIG. 7 is a cut-away view of a further alternative seal used in thecatheter shown in FIG. 2.

FIG. 8 is a cut-away view of a rolling seal used in the catheter shownin FIG. 2.

FIG. 9 is a cut-away view of an accordion seal used in the cathetershown in FIG. 2.

DETAILED DESCRIPTION OF THE INVENTION

The invention set forth below in detail is a sealed catheter having amapping electrode assembly that is utilized, for example, in anelectrophysiology procedure. In one embodiment, the catheter includes aninner member such as an inner tubular member, or a rod that movesaxially with respect to an outer tubular member. The catheter alsoincludes a seal that includes a portion that remains stationary relativeto the inner member during at least a portion of the movement of theinner member. In addition, the seal includes a portion that remainsrelatively stationary with the outer tubular member during at least aportion of the movement of the inner member.

The systems and methods set forth below are not limited to the specificembodiments described herein. In addition, components of each system andsteps of each method can be practiced independently and separately fromother components and method steps described herein. Each component andmethod step also can be used in combination with other catheters,electrodes, systems, and methods.

As used herein, “proximal” refers to the direction away from the body ofa patient and towards a clinician. Furthermore, as used herein, “distal”refers to the direction toward the body of a patient and away from theclinician.

FIG. 2 is a schematic view of a basket electrode mapping catheter 150 inaccordance with one embodiment of the present invention. While FIG. 2 isshown with a basket electrode mapping catheter, other mapping cathetersare within the scope of this invention, including circular mappingcatheters lariat designs, splines, and the like. Catheter 150 includes adistal end 152 and a proximal end 154. An outer tubular member 156extends from distal end 152 to proximal end 154. An inner member 158extends through outer tubular member 156 and is at least partiallyextendable beyond a distal end 160 of outer tubular member 156. A basketelectrode assembly 162 is connected to a distal end 164 of inner member158. In one embodiment, inner member 158 is a rod. In anotherembodiment, inner member 158 is a tubular member. Basket electrodeassembly 162 includes a plurality of arms 166, each including at leastone electrode (not shown in FIG. 2). A set of leads (not shown) extendfrom the electrodes through outer tubular member 156. The leads extendfrom catheter proximal end 154 in a cable 168 that is connected to anEKG recording system, such as EP-Workmate® EP Lab Recording System, orEnSite® System.

Catheter 150 also includes a handle 172 at proximal end 154. Handle 172is utilized to manipulate catheter distal end 152, and morespecifically, basket electrode assembly 162, during operation ofcatheter 150.

FIG. 3 is a schematic view of basket electrode assembly 162 extendedfrom outer tubular member 156. Assembly 162 includes a plurality ofelectrode arms 166, each including a plurality of electrodes 180. Innermember 158 forms a central shaft through basket electrode assembly 162.Assembly 162 includes a cap 182 at a distal tip 184 of inner member 158.Cap 182 is utilized to contain distal ends 186 of arms 166 and isfabricated from a soft polymer such as polyurethane or silicone.Assembly 162 also includes a middle tubular member 188 positionedbetween outer tubular member 156 and inner member 158. A collar 190 isused to attach proximal ends 192 of arms 166 to middle tubular member188. As shown in FIG. 3A, proximal ends 192 of arms 166 pass throughcollar 190 and are attached to middle tubular member 188 by collar 190.A set of wires 194 extends proximally from collar 190 and, in oneembodiment, is connected to EKG recording system 170 (shown in FIG. 2).

FIG. 3 also illustrates a seal member 200 attached to inner member 158and middle tubular member 188. Seal member 200 is configured to preventfluid flow between inner member 158 and middle tubular member 188, whilestill enabling relative axial movement between inner member 158 andmiddle tubular member 188. In one embodiment, basket assembly 162 isextended from outer tubular member 156 through distal movement of bothinner member 158 and middle tubular member 188. Once inner member 158has been extended the proper amount, middle tubular member 188 isfurther extended to bend electrode arms 166 and force them away frominner member 158 and into contact with an interior surface of a heart.Since inner members are formed from resilient material, they are able toapply varying forces to the heart tissue depending on the amount ofdistance between cap 182 and collar 190. Catheter 150 can allow forunimpeded blood flow through the heart during the procedure whileplacing electrodes 180 into contact with a heart chamber wall forin-contact mapping of the physiologic potentials of the heart. In thealternative, catheter 150 can further include a balloon (not shown) toexclude blood flow between arms 166.

FIGS. 4 and 5 are cut-away views of distal end 152 of catheter 150including a seal member 200. FIGS. 4 and 5 are directed to seal member200 that extends between middle tubular member 188 and inner member 158.As such, some of the details of catheter 150 shown in FIG. 3 have beenremoved for clarity. It should be understood, however, that FIGS. 4 and5 illustrate a specific aspect of catheter 150 shown in FIG. 3.

Seal member 200 includes an inner surface 202 and an outer surface 204.In addition, seal member 200 includes a first portion 206 and a secondportion 208. Outer surface 204 of seal member first portion 206 contactsand is attached to an inner surface 210 of middle tubular member 188,and inner surface 202 of seal member second portion 208 contacts and isattached to an outer surface 212 of inner member 158. In one embodiment,portions 206 and 208 are attached to members 188 and 158, respectively,with an adhesive. Alternatively, portions 206 and 208 are attached tomembers 188 and 158, respectively, with a mechanical fastener. Sealmember 200 is placed between the two catheter portions that must besealed, e.g., between middle tubular member 188 and inner tubular member158, or between middle tubular member 188 and outer tubular member 156.

As shown in FIGS. 4 and 5, seal member 200 is a tubular member thatsurrounds inner member 158 and is at least partially contained withinmiddle tubular member 188. During extension of inner member 158, secondportion 208 of seal member 200 moves distally with respect to firstportion 206. FIG. 4 illustrates inner member 158 in a fully extendedconfiguration and FIG. 5 illustrates inner member 158 in a fullyretracted configuration and shows seal member 200 folded upon itself.Seal member 200 is configured to prevent fluid ingress through the spacebetween middle tubular member 188 and inner member 158 while allowinginner member 158 to move a sufficient amount so that basket electrode162 (shown in FIGS. 2 and 3) can be fully deployed during a procedureand fully retracted when not is use, or vice versa. In one embodiment,seal member 200 is fabricated from at least one of polyurethane,silicone, and any other suitable biocompatible material that is flexibleand fluid impermeable.

FIGS. 6 and 7 are cut-away views of distal end 152 of catheter 150including an alternative seal member 220. FIGS. 6 and 7 are directed toseal member 220 that extends between middle tubular member 188 and innermember 158. As such, some of the details of catheter 150 shown in FIG. 3have been removed for clarity. It should be understood, however, thatFIGS. 6 and 7 illustrate an alternative aspect of catheter 150 shown inFIG. 3.

Seal member 220 extends between middle tubular member 188 and innermember 158. Seal member 220 includes a first surface 222 and a secondsurface 224. In addition, seal member 220 includes a first portion 226and a second portion 228. First surface 222 of seal member first portion226 contacts and is attached to an inner surface 230 of middle tubularmember 188. First surface 222 of seal member second portion 228 alsocontacts and is attached to an outer surface 232 of inner member 158. Inone embodiment, portions 226 and 228 are attached to members 188 and158, respectively, with an adhesive. Alternatively, portions 226 and 228are attached to members 188 and 158, respectively, with a mechanicalfastener.

As shown in FIGS. 6 and 7, seal member 220 is a tubular member thatsurrounds inner member 158 and is at least partially contained withinmiddle tubular member 188. During extension of inner member 158, secondportion 228 of seal member 220 moves distally with respect to firstportion 226. FIG. 6 illustrates inner member 158 in a fully extendedconfiguration and FIG. 7 illustrates inner member 158 in a fullyretracted configuration and shows seal member 220 folded upon itself.Seal member 220 is configured to prevent fluid ingress through the spacebetween middle tubular member 188 and inner member 158 while allowinginner member 158 to move a sufficient amount so that basket electrode162 (shown in FIGS. 2 and 3) can be fully deployed during a procedureand fully retracted when not is use. In one embodiment, seal member 220is fabricated from at least one of polyurethane, silicone, and any othersuitable biocompatible material that is flexible and fluid impermeable.

FIG. 8 is a cut-away view of distal end 152 of catheter 150 including analternative seal member 240. As shown in FIG. 8, seal member 240 extendsbetween middle tubular member 188 and inner member 158. As such, some ofthe details of catheter 150 shown in FIG. 3 have been removed forclarity. It should be understood, however, that FIG. 8 illustrates aspecific alternative aspect of catheter 150 shown in FIG. 3.

Seal member 240 is a rolling seal that extends between middle tubularmember 188 and inner member 158. Seal member 240 includes an innersurface 242 and an outer surface 244. In addition, seal member 200includes a first portion 246 and a second portion 248. Outer surface 244of seal member 240 contacts an inner surface 250 of middle tubularmember 188 and an outer surface 252 of inner member 158. In oneembodiment, outer surface 244 of seal member 240 is not attached toeither middle tubular member 188 or inner member 158, but rather is heldstationary with regard to inner surface 250 and outer surface 252 withfriction between surfaces 244, 250, and 252.

As shown in FIG. 8, seal member 240 is a ring member that surroundsinner member 158 and is at least partially contained within middletubular member 188. Seal member 240 is thus able to move with a rollingmotion during relative movement between middle tubular member 188 andinner member 158. Seal member 240 is configured to prevent fluid ingressthrough the space between middle tubular member 188 and inner member 158while allowing inner member 158 to move a sufficient amount so thatbasket electrode 162 can be fully deployed during a procedure and fullyretracted when not is use.

Seal member 240 includes an inner chamber 254 that contains a fluid. Inone embodiment, the fluid is at least one of a gas, such as CO₂, and aliquid such as silicone gel, water, saline solution, and otherbiocompatible materials. In one embodiment, seal member 240 isfabricated from at least one of polyurethane, silicone, and any othersuitable biocompatible material that is flexible and fluid impermeable.

FIG. 9 is a cut-away view of distal end 152 of catheter 150 including afurther alternative seal member 260. FIG. 9 is directed to seal member260 that extends between middle tubular member 188 and inner member 158.As such, some of the details of catheter 150 shown in FIG. 3 have beenremoved for clarity. It should be understood, however, that FIG. 9illustrates a specific alternative aspect of catheter 150 shown in FIG.3.

Seal member 260 extends between middle tubular member 188 and innermember 158. Seal member 260 includes an inner surface 262 and an outersurface 264. In addition, seal member 260 includes a first portion 266and a second portion 268. Outer surface 264 of seal member first portion266 contacts and is attached to an inner surface 270 of middle tubularmember 188, and inner surface 262 of seal member second portion 268contacts and is attached to an outer surface 272 of inner member 158. Inone embodiment, portions 266 and 268 are attached to members 188 and158, respectively, with an adhesive. Alternatively, portions 266 and 268are attached to members 188 and 158, respectively, with a mechanicalfastener.

As shown in FIG. 9, seal member 260 is a tubular member that surroundsinner member 158 and is at least partially contained within middletubular member 188. During extension of inner member 158, second portion268 of seal member 260 moves distally with respect to first portion 266.FIG. 9 illustrates inner member 158 in a fully retracted configurationand shows seal member 260 folded upon itself. Seal member 260 isconfigured to prevent fluid ingress through the space between middletubular member 188 and inner member 158 while allowing inner member 158to move a sufficient amount so that basket electrode assembly 162 (shownin FIGS. 2 and 3) can be fully deployed during a procedure and fullyretracted when not is use. In one embodiment, seal member 260 isfabricated from at least one of polyurethane, silicone, and any othersuitable biocompatible material that is flexible and fluid impermeable.

Catheter 150 is utilized by inserting distal end 152 into a patient'svascular system and maneuvering distal end to an appropriate locationwithin a patient's heart. Once distal end 152 is properly positioned,handle 172 is manipulated so that basket electrode assembly 162 isextended beyond outer tubular member distal end 160. Basket electrodeassembly 162 is moved distally beyond outer tubular member 156 by distalmovement of middle tubular member 188 and inner member 158. Once basketelectrode assembly 162 is extended beyond outer tubular member 156, themovement of inner member 158 is stopped while middle tubular member 188is further extended distally, thus bending electrode arms 166 radiallyoutwardly. Basket electrode assembly 162 is then maneuvered to properlyposition electrodes 180 and energy is applied to electrodes 180 so thatan electric field is created in the heart. Readings are taken andinformation is processed so that, for example, a proper reading of theheart is obtained. Basket electrode assembly 162 is retracted into outertubular member 156 and catheter 150 is then removed from the patient'svascular system.

Exemplary embodiments of catheters, electrode assemblies, and methods ofassembly are described in detail above. The catheter, electrodeassemblies, and methods are not limited to the specific embodimentsdescribed herein, but rather, components of the catheter and electrodeassembly and/or steps of the methods may be utilized independently andseparately from other components and/or steps described herein. It isnoted that the exemplary embodiments can be implemented and utilized inconnection with many other ablation applications.

Although specific features of various embodiments of the invention areshown in some figures and not in others, this is for convenience only.In accordance with the principles of the invention, any feature of afigure may be referenced and/or claimed in combination with any featureof any other figure.

This written description uses examples to disclose the invention,including the best mode, and also to enable any person skilled in theart to practice the invention, including making and using any devices orsystems and performing any incorporated methods. The patentable scope ofthe invention is defined by the claims, and may include other examplesthat occur to those skilled in the art. Such other examples are intendedto be within the scope of the claims if they have structural elementsthat do not differ from the literal language of the claims, or if theyinclude equivalent structural elements with insubstantial differencesfrom the literal languages of the claims. For example, although a threemember catheter with a distal seal located between two of the members isdescribed above, it should be understood that any number of tubes can beutilized in the catheter as long as a seal is positioned between, andcontacts, two longitudinally extending members.

What is claimed is:
 1. A catheter system comprising: a flexible, tubularouter member sized and configured for insertion into a living body; aflexible inner member extending through at least a portion of said outermember, said inner member movable axially relative to said outer member;and a rolling seal comprising a first portion and a second portion, saidseal extending between said outer member and said inner member, saidsecond portion of said seal remaining stationary relative to said innermember during relative axial movement between said tubular outer memberand said inner member.
 2. A catheter in accordance with claim 1 whereinsaid inner member comprises at least one of a rod and an inner tubularmember.
 3. A catheter in accordance with claim 1 further comprising anouter tubular sheath, said outer member extending at least partiallythrough said outer tubular sheath, said inner member comprises an innertubular member, said catheter system further comprising a basketelectrode assembly connected to a distal end of said inner tubularmember and configured to be extended from, and retracted into, saidouter tubular sheath.
 4. A catheter in accordance with claim 1 whereinsaid rolling seal is configured to roll along both said inner member andsaid outer member when relative movement occurs between said innermember and said outer member.
 5. A catheter in accordance with claim 1wherein said seal comprises a cavity at least partially filled with afluid.
 6. A catheter in accordance with claim 5 wherein said fluidcomprises at least one of CO₂, silicone gel, water, saline solution, anda biocompatible material.
 7. A medical kit comprising: a flexible,tubular outer sheath; a flexible inner catheter extending through atleast a portion of said outer sheath; and a rotatable seal comprising afirst portion and a second portion, said first portion configured tocontact said outer sheath, said second portion configured to contactsaid inner catheter, wherein said rotatable seal is configured to rotatealong both said inner catheter and said outer sheath when relativemovement occurs between said inner catheter and said outer sheath.
 8. Acatheter in accordance with claim 7 wherein said second portion of saidseal member is configured to remain stationary relative to said innercatheter during relative axial movement between said outer sheath andsaid inner catheter.
 9. A catheter in accordance with claim 7 whereinsaid seal member is configured to prevent fluid flow between said outersheath and said inner catheter.
 10. A catheter in accordance with claim7 wherein said inner catheter comprises a tubular member.
 11. A catheterin accordance with claim 7 wherein said seal comprises a cavity at leastpartially filled with a fluid.
 12. A catheter in accordance with claim11 wherein said fluid comprises at least one of CO₂, silicone gel,water, saline solution, and a biocompatible material.
 13. A cathetersystem in accordance with claim 1 wherein said system is configured suchthat said seal is positionable within a body of a patient.